New client relationships are exciting in any business. But they don’t get much more gratifying than the ones we’ve been fortunate to make. Looking back over the last six months of new client relationships, I’ve been struck with the emergence of some inspiring trends. A focus on personalized medicine. The willingness to take on looming problems in population health. The application of advanced computing and “big data” to challenges old and new. It’s been a potent reminder of the impact that our work here at OpenClinica makes possible.

Here is just a sample of the new partners that are energizing us:

The biotechnologists at miR Diagnostics specialize in the development of prognostic testing in cancer treatment. Their mission is to provide people diagnosed with cancer a deeper understanding their disease, and to help them make the safest, most informed treatment decisions possible. Using state of the art research, miR Diagnostics has developed cutting-edge, prognostic cancer testing systems that provide insight into tumor progression previously impossible to ascertain.

With Tools4Patient, too, medicine is personal. Tools4Patient develops companion diagnostics which contribute to the design of new treatment paradigms to improve outcomes and enhance quality of life for patients. Their first commercialized tool, Placebell, increases the sensitivity and power of clinical research results through improved Individual Placebo Response characterization.

Mercy Research, a centralized, multi-faceted research group within the Mercy health system, conducts more than 700 clinical studies at any given time. They’ve developed more than 40 innovating products and are now building one of the foremost teams for healthcare analytics. Suffice it to say, we’re proud to play our role in this enormous enterprise.

Malaria is responsible for more childhood mortality than any other single infectious agent. At Sanaria, through collaborations with renowned institutions like University of Tübingen, Germany, research is taking on a big aim: eradication through vaccination.

Biolux Research develops technologies that enhance clinical outcomes and dramatically reduce treatment timelines in dentistry, implantology and orthodontics in a safe, effective and non-invasive approach. Learn how they’ve already succeeded with OrthoPulse®.

Again, these are only examples. In the space of a blog post, I can’t do justice to these missions, those of the new clients I didn’t mention, and the many we’ve been helping to advance for years. But I will be reporting our progress in making all these ventures like these as successful as they can be.

OpenClinica has welcomed several new team members over the last few months. We’ve collected some eCRFs (Collegue Revelation Forms) to introduce them!

Name: Paul BowenTitle: Product OwnerResponsibility: I bridge the gap between our stakeholders and our engineering team to ensure that we build the features into OpenClinica that are needed most.Background: Prior to joining OpenClinica, I spent ten years at Quintiles/Outcome Sciences developing an EDC platform for late phase studies. I also spent one year at Clinical Ink working on a patient engagement app.What I love about research: I like being a part of something that is making people’s lives better in a significant way.What I love about technology: Technology provides us with many new options to improve the way we do research. Working to figure out the best solutions is a fun part of this job.What I love outside of work: When the weather is nice, my girlfriend and I like taking long walks with our dog. When it’s not as nice, we like watching sci-fi TV and movies.

Name: Bryan FarrowTitle: eClinical CatalystResponsibility: I’m the link between the data management community and OpenClinica. It’s my job to distribute news about our products and services to data managers who’ve been looking for solutions to industry-wide problems like integration and ease of use. Just as importantly, I bring unmet challenges back to our incredible team of developers and customer success professionals so that we can find a solution.Background: Prior to joining OpenClinica, I spent five years at DrugDev, learning how just how much technology can affect the duration, cost and experience of running a trial. Prior to that, I was responsible for physician and patient communications at Boston Children’s Hospital.What I love about research: The journey and the destination. Asking questions, devising ways to get an answer, and analyzing evidence are thrilling. With clinical research, we get to do all that with the aim of improving lives.What I love about technology: For me, technology comes down to problem-solving. If you’re curious and persistent, you can always find a better way. And it’s so gratifying when you do.What I love outside of work: My family above all. I love being a father to my two kids and a partner to my incredible wife. But when I need some “me time”, I usually reach for a book or journal dealing with philosophy. That was my major in college, and I’m still enamored with the power of logic and the gravity of big ethical and political questions.

Name: Brittany StarkTitle: Project ManagerResponsibility: I direct client projects involving the implementation of clinical trials using OpenClinica software. I oversee the planning, build, testing, and delivery of client projects on time, within scope and budget.Background: Prior to joining OpenClinica, I spent 4 years in the Cancer Clinical Trials Office at Beth Israel Deaconess Medical Center, working with phase 0-IV clinical trials in oncology. During this time, I gained experience as a Clinical Research Coordinator, Regulatory Affairs Specialist and later Clinical Trials Staff Educator. Prior to this, I spent over 4 years working in academia at the University of Kentucky (in a Human Behavioral Pharmacology and Clinical Psychology Lab) and later at the University of Maine (teaching SPSS as part of a Research Methods and Designs Course Lab).What I love about research: The potential to advance our understanding of the world we live in and change lives for the better.

Name: Chris WhiteTitle: Customer Success Team LeadResponsibility: I direct client projects involving the implementation of clinical trials using OpenClinica software. I oversee the planning, build, testing, and delivery of client projects on time, within scope and budget.Background: Prior to joining OpenClinica, I spent two years in the consulting industry working with many different types of software. Prior to that, I spent 14 years creating positive customer experiences with two successful start-ups, helping to build their client focused operations.What I love about research: There is still part of me that is the seven-year-old Calvin (from Calvin and Hobbes), always asking questions, wanting to know and understand the wide world around me.

Patient-reported outcomes give us insights that no clinical assessment, imaging study and lab report can. For subjective measures, such as mood or energy level, there’s often no other source. But common methods of collecting PRO, from paper diaries to provisioned devices, pose real barriers. We want to know which ones you’ve faced. Tell us by completing the form below. We have more to say on the topic, but we want to start with your experiences!

We’re bring OpenClinica Super User Training to Brussels, December 6-9. This is a great opportunity to get in-depth, hands-on instruction around building studies and best practices. Registration deadline is November 23rd.

I recently delivered a webinar titled “Getting Started with eCOA/ePRO,” in which roughly a third of attendees polled cited expense as the number one reason that has prevented them from adopting an ePRO solution. So what does ePRO really cost? Is it worth it? Here I strive to provide a basic, high-level framework for thinking about the return on investment ROI of eCOA vs. paper.

Let’s start by taking a look at the costs that are unique to each approach.

Paper

In a traditional paper based model, you are incurring costs that stem from printing, mailing, data entry, and data cleaning. These are all expenses than can be estimated with a fair degree of accuracy, with the cost of data entry being the most significant of these. To estimate the cost of data entry, see how long it takes to key in a subject completed paper casebook, multiply this by your cost of labor (don’t forget to include overhead!).

ePRO

The cost side for ePRO is similarly straightforward, but the expense elements are different. You’re either building an ePRO system (which will almost carry a highly unpredictable cost) of buying one (much more predictable cost). Assuming you’re buying, here are the costs you may expect to incur:

You should evaluate whether your study and selected ePRO system will allow for patients to use their own devices, or if you will need to provision devices (or some mix thereof). The cost of provisioning devices, especially for a global study can be significant—in addition to the costs of the devices themselves, you will need to consider the costs of data plans, and logistics associated with supporting the devices. I’m a big fan of BYOD (bring your own device) but, depending on the study, it may not be feasible to utilize while maintaining scientific validity of data collected.

Once you’ve mapped out your costs of each route, you can begin to weigh these against the benefits of going eCOA.

Paper vs. eCOA

When you boil it down, people employ ePRO/eCOA to maximize data quality, increase productivity, and/or enable new capabilities that help answer their research questions. ePRO is e-source, so you don’t have worry about administering a paper data entry process. Depending on the study, the cost savings from this alone might justify ePRO.

There are some additional benefits ePRO offers over paper that may be harder to quantify, but nonetheless very real. For example, there are clear data quality benefits to ePRO. The electronic system can ensure a minimum standard of data quality through edit checks and enforced data structures. ePRO data will always be cleaner than the same data captured on paper.

The use of an ePRO system also allows you to know for sure when the data were recorded. For instance, patients can be reminded automatically when their diaries are overdue, and you now only have much stronger assurances that data were collected at the appropriate time (vs paper), you can also more easily monitor the study progress.

Bypassing manual data entry and having the system provide notifications to subjects to ensure data are captured in a timely way might allow for faster and better in-study decision making and even may accelerate study closeout. Also, an increasing amount of evidence exists that mobile-based messaging and communication strategies help increase patient engagement and treatment adherence. And of course, not having to deal with a stack of paper during a site visit might allow the clinician’s interaction with the patient to be higher quality.

Quantifying the benefits of all of these things can be tough, but start with those which are most quantifiable and see if those items alone these alone provide a compelling ROI (from my experience they often do). Then the less tangible benefits become gravy to the ROI argument. When modeling costs over time and a pay-back period, keep in mind that ePRO will typically carry a higher upfront cost than paper, with the cost saving benefits realized downstream over time. With today’s technologies, even most smaller studies should be able to realize a positive payback.

Naturally, there may be additional ROI factors to consider which are specific to your situation. If you have particular thoughts, questions, or experiences on this topic I encourage you to add a comment to this post.

The program for OC14 (the 2014 OpenClinica Global Conference) has been posted–what a line-up! Having been involved in each of the past 5 OC conferences, I can say that this one has a lot new and useful things to offer. Many in the OpenClinica community are not aware of all the useful innovations produced by our community scattered throughout the globe. The theme of the conference is “An Ecosystem of Innovation,” and OC14 will help to communicate a number of the innovations available to you and show you how you can take advantage of them for your own work.

OC14 is a unique opportunity to enhance your capabilities and skills with OpenClinica in an information-packed 2 days, June 22-23 in Boston. Early bird deadline registration is May 2nd.

That’s right–there are only 6 days left to submit proposals for participation in the 2014 OpenClinica Conference, June 22-23 in Boston. This is a unique opportunity to present at the premier OpenClinica event headlined by luminary Dr. Eric Perakslis, Executive Director of the Harvard Center for Biomedical Informatics and former Chief Information Officer at the U.S. FDA. Share your knowledge and experience, learn from others, and build valuable relationships.

Here are 4 ways to participate:

Presenting a session at OC14 is a great way to share your OpenClinica work and experience. Format can be lecture, panel discussion, or other creative idea.

Showing a demo can be a great way to get show your OpenClinica related technology in a hands-on way while obtaining direct feedback

Leading a workshop gives you a chance to take a deep dive into subject matter you have mastered.

Or, join as an attendee to soak it all in!

Learn more and submit your proposal at www.oc14.org. Deadline for submissions is March 31st.

While tablet software maker Mi-Co is showcasing an integration of their Mi-Forms tablet-based forms software with OpenClinica that can be used in “offline” settings, elsewhere within the OpenClinica community, Raymond Omollo and Michael Ochieng have developed a separate option for using OpenClinica in settings without internet connectivity. Their method synchronizes multiple locally deployed instances of OpenClinica with a central OpenClinica database. Michael and Raymond recently presented their work at the OC13 conference. You can access their presentation slides here to see how they address key issues such as synchronization, back-ups, encryption, and user training.

Synchronization Flow Chart

While working for Drugs for Neglected Diseases initiative (DNDi), Michael and Raymond devised this approach for a WHO study of Buruli ulcers in West Africa (Ghana and Benin). The study, which is ongoing as of the date of this post, is a randomized controlled trial comparing the efficacy of 8 weeks treatment with clarithromycin and rifampicin versus streptomycin and rifampicin. It involves 430 subjects across 5 sites. The participating sites have limited or unstable internet connectivity, so a solution is needed that provided timely, auditable, and quality data entry given this constraint. A positive byproduct is enhancing the capacity of these disconnected sites to utilize EDC.

As they say, necessity is the mother of invention. And open source makes it easier for people to believe that what is necessary can in fact be accomplished. Kudos to Raymond and Michael for devising a solution that works for them. Perhaps it may work for others as well. If you’d like to access the source code and documentation for their work, you can download these from the OpenClinica Tools and Tips page (scroll to bottom). You can reach Raymond and Michael on the OpenClinica Developers mailing list: developers@openclinica.org.

– Ben Bauman

More About DNDi

Headquarted in Geneva, DNDi is a global organization that develops safe, effective, and affordable treatments for neglected diseases. The neglected diseases that DNDi tackles afflict many of the world’s poorest people (Malaria, Leishmaniasis, Chagas disease, Sleeping Sickness, Paediatric HIV, Filaria). DNDi’s goal to develop 11 to 13 new treatments by 2018. More at www.dndi.org.